Responsibilities: Resolution of fundamental Computer System Validation compliance issues on assigned projects. Writing, reviewing, and executing computer validation documentation. Perform computer system validation activities related to process control systems of pharmaceutical water for injection system, water pretreatment system, water stills and high-quality steam generation systems. Validation of computerized systems, in accordance with GAMP5 and V-Model (USR, Function Specification, IQ/OQ/Protocol/Report/Testing, Traceability Matrix, Validation Report). ssessing electronic/paper records aiming to identify Data Integrity gaps with Risk-Based Approach to suggest the most appropriate mitigation/remediation actions. Ensuring that all project-related issues and deviations are recorded, approved and dispensed accordingly. Preparation of project and life-cycle reports and review/approve all other documents to ensure compliance with SOP. Ensuring that all project and lifecycle documents achieve the goal of traceability, and are all retained in the document repository (Document Navigator) and approved following the prescribed SOP. Requirements: t least 8 years s of experience in the pharmaceuticals field, with focus on Computer System Validation. Previous work experience in computer system validation of PLC's, HMI's, SCADA and historian. Experienced in computer system validation of Rockwell Factory Talk, Microsoft SQL Server, Microsoft NET Framework and Allen Bradley PLC systems preferably related to process control systems. bility to perform input and output testing. Strong understanding of FDA regulations for commissioning, validation, and lifecycle management of GMP equipment and process control systems. Strong knowledge in good documentation practices. Knowledge of Data Integrity Assurance according to EU GMP Annex1, US FDA Annex 11. Knowledge of regulations and guidelines applicable to computerized and automated systems (GAMP, 21 CFR part 11). Katalyst Healthcares and Life Sciences
...also offering a housing allowance of $1,000, grossed up, for up twelve months for this position for a new hire who relocates Relocation assistance is available Who We Are: At Los Alamos Medical Center, we work hard to provide high quality care thats continuously...
...Junior Instructional Designer Location: Remote, must be in Michigan Pay Rate: Up to $32/hour, DOE (W2 and benefit options Duration:... ...evolving business needs. Develop storyboards, scheduling production activity, conducting research and assuring an overall...
...Management Development Program today and you could be running a wedding venue within 6 - 12 months. This proven training program... ...hosting events from food logistics to staff scheduling, and revenue planning to vendor partnership building. You'll very quickly learn how to...
***CADC intern, CADC or LCADC in NJ required!Schedule: Monday-Friday 5a-1:30ppARS Treatment Centers specialize in outpatient... ...and strategic plan . We are currently seeking a Substance Abuse Counselor to join our team!ARS rewards it's employees for their hard...
...compassionate individuals looking to make a difference in the lives of seniors. The position typically entails two outings a week that last... .... Responsibilities Perform safety checks on the bus each time before operation. Drive the community bus in a safe manner...